Regulatory Affairs Support

Regulatory Affairs SupportAs international Health Authorities’ medical device review processes become more complicated, partnering with an experienced regulatory advisory company can make a significant difference in your compliance efforts. Whether your goal is to develop the rationale for substantial equivalence of your medical device, confirm your regulatory pathway and reimbursement strategy, prepare for and obtain market approvals, a skilled regulatory consulting firm can assist you in your effort to meet all regulatory requirements. Founded in 2002, AlvaMed has extensive experience providing regulatory consulting to all sizes of medical device manufacturers seeking to bring their products to the US and European markets. We have assisted with the launch of more than 100 new medical devices.

Services Offered:

  • Medical device regulatory strategy
  • Medical device reimbursement assessment
  • Medical device classification
  • FDA pre-submission meetings
  • Submissions for 510k clearance, PMA and CE Mark
  • eMDR adverse event reporting
  • From 483 and Warning letter analysis, response and recovery
  • Medical device UDI consulting and training
  • ISO 14971 risk management consulting for medical device companies
  • On-site group ISO 14971 training for medical device companies
  • Postmarket surveillance

Case Studies:

GMP and CE Certification
Regulatory Strategy